The following data is part of a premarket notification filed by Ge Healthcare with the FDA for C1-6-d Ultrasound Transducer.
| Device ID | K122921 |
| 510k Number | K122921 |
| Device Name: | C1-6-D ULTRASOUND TRANSDUCER |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | GE HEALTHCARE 9900 W INNOVATION DRIVE Wauwatosa, WI 53226 |
| Contact | Bryan Behn |
| Correspondent | Bryan Behn GE HEALTHCARE 9900 W INNOVATION DRIVE Wauwatosa, WI 53226 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-24 |
| Decision Date | 2012-10-05 |
| Summary: | summary |